BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGAT

    MDR report key: 1823837 · Received December 12, 2007

    Report

    Report Number
    1527736-2007-08461
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Date of Event
    October 9, 2007
    Report Date
    December 3, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE THE DEVICE DID NOT CLIP PROPERLY ON THE CYSTIC DUCT/ARTERY, NO FURTHER INFORMATION WAS PROVIDED. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGAT FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4J42T

    Patients

    Seq Age Sex Outcome Treatment
    1